Customize
K2214323D-Side SA · cleared 2022-08-03 · product code QIH · Radiology
Premarket evidence — what FDA accepted
source quote (p.3)
“Customize for ankle arthroplasty is intended to be used as a software interface to assist in: Visualization, modification, validation of the planning of total ankle arthroplasty”
source quote (p.5)
“Both devices implement artificial intelligence including nonadaptive machine learning, followed by human supervision.”
source quote (p.5)
“Both devices implement artificial intelligence including nonadaptive machine learning, followed by human supervision.”
Validation studies (3)
Bench
sample size not stated
endpoints: segmentation validation of the Customize software
standards: FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
Bench
sample size not stated
endpoints: Repeatability and Reproducibility (R&R) study on the segmentation of ankle anatomies
standards: FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
Bench
sample size not stated
endpoints: accuracy study on 3D model generation for tibia and talus
standards: FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices”
Reported performance (0 observations)
FDA source did not state a quantitative performance metric — non-reporting is itself the signal.
Each value carries its own analysis unit and task — never compare or pool across devices. Source: 510(k) summary PDF.
Predicate network
Postmarket — what happened after clearance
Recall and MAUDE counts are product-code-level (reports aren't reliably attributable to one device). Signals are descriptive observables with sources — never a judgment that the device is unsafe or drifting. Snapshot 2026-07-08.
Reimbursement — how devices like this got paid
Not yet tracked — no payment pathway indexed for this clearance (the reimbursement corpus is a growing seed set).